CN109248155B - Roxithromycin capsule and preparation process thereof - Google Patents
Roxithromycin capsule and preparation process thereof Download PDFInfo
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- CN109248155B CN109248155B CN201811132361.6A CN201811132361A CN109248155B CN 109248155 B CN109248155 B CN 109248155B CN 201811132361 A CN201811132361 A CN 201811132361A CN 109248155 B CN109248155 B CN 109248155B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/485—Inorganic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
Abstract
The invention relates to a roxithromycin capsule and a preparation method thereof, wherein the roxithromycin capsule is prepared from the following components in percentage by weight:
Description
Technical Field
The invention relates to the technical field of pharmaceutical preparations, in particular to a roxithromycin capsule and a preparation process thereof
Background
Roxithromycin, the chemical name of which is 9- [ O- [ (2-methoxyethoxy) -methyl ] hydroxyimino ] erythromycin, has the molecular formula of C41H76N2015 and the structural formula as follows:
roxithromycin is a semisynthetic 14-membered ring macrolide antibiotic, is a derivative of erythromycin obtained by a C9 bit structure, and the preparation original research company is Sanofi-Aventis, and is firstly marketed in France as 150mg standard tablets, which is suitable for pharyngitis and tonsillitis caused by Streptococcus pyogenes, sinusitis, otitis media, acute bronchitis and acute attack of chronic bronchitis caused by sensitive bacteria, and pneumonia caused by Mycoplasma pneumoniae or Chlamydia pneumoniae; urethritis and cervicitis caused by chlamydia trachomatis; infection of skin soft tissue by sensitive bacteria.
The inventor discovers that the roxithromycin has adhesiveness, even if the medicine is prepared into granules and then encapsulated, a small amount of medicinal powder or medicinal granules still adhere to a capsule shell when the content of the capsule is poured out, and the inventor discovers that the roxithromycin capsules prepared by the prior art have the phenomenon, so that the capsule shell adhered with the medicinal powder or the medicinal granules often floats when the dissolution rate of the roxithromycin capsules is detected, and the unstable dissolution curve influences the detection result due to the adhesion effect, thereby bringing difficulty to the detection work of the medicine.
Disclosure of Invention
In order to overcome the problems, the invention screens the preparation process and auxiliary materials of the roxithromycin capsule through tests, overcomes the defects of the prior art through process optimization, and effectively prevents the medicinal powder or medicinal granules from being adhered to the capsule shell.
The invention provides a roxithromycin capsule which is prepared from the following components in percentage by weight:
wherein the binder is polyvinylpyrrolidone; the wetting agent is selected from sodium dodecyl sulfate, tween 80 and poloxamer; the lubricant is selected from one or more of superfine silica gel powder, magnesium stearate, talcum powder or the like. Preferably, the roxithromycin capsule provided by the invention is prepared from the following components in percentage by weight:
most preferably, the roxithromycin capsule provided by the invention is prepared from the following components in percentage by weight:
the invention further provides a preparation method of the roxithromycin capsule, which comprises the following steps:
a. firstly, pulverizing roxithromycin, sieving the roxithromycin by a 100-mesh sieve, respectively sieving corn starch and low-substituted hydroxypropyl cellulose for later use, and then preparing poloxamer and polyvinylpyrrolidone aqueous solution for later use;
b. weighing and adding roxithromycin, corn starch and low-substituted hydroxypropyl cellulose as raw auxiliary materials, uniformly mixing, and preparing a soft material by using poloxamer and polyvinylpyrrolidone aqueous solution;
c. drying the soft material in a drying box, and sieving the dry particles with a 20-mesh sieve for finishing the particles;
d. weighing the externally added auxiliary materials, mixing the silica gel with the dry particles uniformly, filling capsules and packaging.
Wherein, the roxithromycin is crushed and sieved by a 100-mesh sieve, and the corn starch and the low-substituted hydroxypropyl cellulose are respectively sieved by the 100-mesh sieve in the step a; the mixing time in the step b is 5-10 minutes; the drying temperature in the step c is 55-65 ℃, and the mixing time in the step b is 10 minutes; the drying temperature in step c is 60 ℃.
Among the adjuvants selected in the present invention, wherein: the corn starch has no hygroscopicity, has good solubility, is more beneficial to the release of the main drug in the capsule than other fillers, and is beneficial to improving the dissolution efficiency. The low-substituted hydroxypropyl cellulose can quickly absorb water and expand due to larger surface area and porosity of the powder, can well overcome the self viscosity of the raw materials, and effectively prevent the situation that the capsule can not be completely disintegrated due to the adhesion between the medicinal powder and the medicinal granules and the capsule shell.
The polyvinylpyrrolidone was formulated as a 2% by weight aqueous solution during use. Poloxamer 188 is used as wetting agent, and is dissolved in pure water at about 70 deg.C, and can be mixed with polyvinylpyrrolidone to make into water solution. The superfine silica gel powder belongs to a hydrophilic lubricant, and is beneficial to overcoming the viscosity of raw materials, and the hydrophobic lubricant is easy to cause the adhesion of medicinal powder and medicinal granules with a capsule shell so as to cause incomplete disintegration.
In the above composition, the roxithromycin is a conventional raw material medicine sold in the market, and the capsule can be prepared by a common capsule production technology, wherein the capsule production technology comprises the steps of raw material crushing, sieving, premixing, wet granulation, drying, total mixing and the like. The inventor of the invention finds through experiments that the existing roxithromycin capsules are often adhered with medicinal powder or medicinal granules on the capsule shells when the dissolution rate is measured, in the process of carrying out dissolution test, the dissolution conditions of 6 capsules are simultaneously examined by the same batch of samples, the sampling points are respectively 5, 10, 15, 30, 45 and 60min, if the medicament is adhered to the capsule shells, some capsules are adhered to a lot, and some capsules are not adhered to one another, so that the dissolution rate of different particles at the same sampling time point is greatly different (plus or minus 5 percent, namely 10 percent difference between the largest and the smallest) at the same sampling time point; secondly, the dissolution rate of the roxithromycin capsules is required to reach more than 85% at 30min, but if some capsules are dissolved by 86%, some capsules are dissolved by 92% and some capsules are dissolved by 95%, although the dissolution limit is reached, obvious inter-particle difference is shown, and the quality is unstable due to the difference.
In the process of researching the existing roxithromycin capsules, the invention discovers that the low-substituted hydroxypropyl cellulose is used as a disintegrating agent, and particularly when the low-substituted hydroxypropyl cellulose is used by more than 10%, the disintegrating effect of the preparation can be greatly improved, and the adhesion problem can be solved.
The invention screens the types of the disintegrating agents, uses a plurality of disintegrating agents, and comprises the following screening process experiments:
the experimental method comprises the following steps:
according to the formulation and preparation method of example 4 and example 5, under the condition that other components and proportion are not changed, roxithromycin particles are prepared by adopting different types of disintegrating agents and filled into capsules, and under the condition of the same dosage, the disintegration time is examined according to 0921 disintegration time limit inspection method of the fourth general rule of Chinese pharmacopoeia 2015 edition; according to the test method of the dissolution rate and the release rate of 0931 in the fourth part of the Chinese pharmacopoeia 2015 edition and the standard dissolution rate item of the roxithromycin capsules in the second part of the Chinese pharmacopoeia 2015 edition, the dissolution rate and the dissolution phenomenon are examined.
The experimental results are as follows:
the preparation process of the roxithromycin capsule composition is simple and easy to implement, and the product quality and stability are obviously superior to those of products on the market through experimental verification.
The present invention will be described more specifically with reference to the following specific examples, but the present invention is not limited to the following examples. Wherein the content (%) means a weight percentage. Example 1 preparation of roxithromycin capsules of the invention were prepared according to the following formula:
the preparation method comprises the following steps:
a. firstly, pulverizing and sieving roxithromycin, and then preparing PVP K30 and poloxamer water solution for later use;
b. weighing the internally added raw and auxiliary materials of roxithromycin, low-substituted hydroxypropyl cellulose and corn starch, uniformly mixing, and preparing a soft material by using PVPK30 and poloxamer aqueous solution;
c. directly placing in a drying oven for drying, and sieving the dried granules with a 20-mesh sieve for finishing;
d. weighing silica gel micropowder, magnesium stearate, and pulvis Talci, mixing with the dry granule, making capsule, and packaging.
Example 2 preparation of Roxithromycin capsules according to the invention
Prepared according to the following formula:
the preparation method comprises the following steps:
a. firstly, pulverizing and sieving roxithromycin, and then preparing PVP K30 and poloxamer water solution for later use;
b. weighing the internally added raw and auxiliary materials of roxithromycin, low-substituted hydroxypropyl cellulose and corn starch, uniformly mixing, and preparing a soft material by using PVPK30 and poloxamer aqueous solution;
c. directly placing in a drying oven for drying, and sieving the dried granules with a 20-mesh sieve for finishing;
d. weighing silica gel and pulvis Talci, mixing with the dry granules, making into capsule, and packaging.
EXAMPLE 3 preparation of Roxithromycin capsules according to the invention
a. Firstly, pulverizing and sieving roxithromycin, and then preparing PVP K30 and poloxamer water solution for later use;
b. weighing the internally added raw and auxiliary materials of roxithromycin, low-substituted hydroxypropyl cellulose and corn starch, uniformly mixing, and preparing a soft material by using PVPK30 and poloxamer aqueous solution;
c. directly placing in a drying oven for drying, and sieving the dried granules with a 20-mesh sieve for finishing;
d. weighing silica gel powder as the additional auxiliary material, uniformly mixing with the dry granules, filling into capsules, and packaging.
Example 4 preparation of Roxithromycin capsules according to the invention
The preparation method comprises the following steps:
a. firstly, pulverizing and sieving roxithromycin, and then preparing PVPK30 and poloxamer aqueous solution for later use;
b. weighing the internally added raw and auxiliary materials of roxithromycin, low-substituted hydroxypropyl cellulose and corn starch, uniformly mixing, and preparing a soft material by using PVPK30 and poloxamer aqueous solution;
c. directly placing in a drying oven for drying, and sieving the dried granules with a 20-mesh sieve for finishing;
d. weighing silica gel powder as the additional auxiliary material, uniformly mixing with the dry granules, filling into capsules, and packaging.
EXAMPLE 5 preparation of Roxithromycin capsules according to the invention
Prepared according to the following formula:
the preparation method comprises the following steps:
a. firstly, pulverizing and sieving roxithromycin, and then preparing PVP K30 and poloxamer water solution for later use;
b. weighing the internally added raw and auxiliary materials of roxithromycin, low-substituted hydroxypropyl cellulose and corn starch, uniformly mixing, and preparing a soft material by using PVPK30 and poloxamer aqueous solution;
c. directly placing in a drying oven for drying, and sieving the dried granules with a 20-mesh sieve for finishing;
d. weighing silica gel powder as the additional auxiliary material, uniformly mixing with the dry granules, filling into capsules, and packaging.
Test example 1
Disintegration experiments were performed on the capsules of examples 1-5 of the present invention
The method comprises the following steps: the disintegration time in the dissolution cup was measured for the capsules according to the dissolution rate test method (0931, the four general guidelines in the chinese pharmacopoeia 2015 edition).
TABLE 1
Wherein the reference formulation is Sanofi-Aventis, first marketed in France as 150mg size Roxithromycin capsules.
The above test results show that examples 4 and 5 are the preferred formulations of the present invention, and have good disintegrability,
the disintegration time period is the same compared to the reference formulation.
Test examples 1 and 2 test of adhesion between medicinal powder and granule and capsule shell
The capsules obtained in examples 1,2,3,4 and 5 were simultaneously examined in the dissolution test with the reference preparation, and the dissolution phenomena in the dissolution cup were observed and compared.
Examples 4 and 5 can overcome the self-viscosity of the raw materials well, and effectively prevent the adhesion between the medicinal powder and the capsule shell, and the adhesion between the reference preparation exists, and the experiments prove that the invention is superior to the reference preparation.
Meanwhile, the dissolution curve is examined and detailed in test example 3, and the experimental data further illustrate the influence of the adhesion of a small amount of contents in the capsule on the detection work and results.
Test example 3 examination of dissolution Curve
The method comprises the following steps: according to a dissolution determination method (a second method of 0931 in the general rules of the four parts of the version 2015 in the Chinese pharmacopoeia, a settling basket), phosphate buffer solution (pH6.8) (0.2mol/L potassium dihydrogen phosphate solution, 27.22g of potassium dihydrogen phosphate is weighed and dissolved in 1000ml of purified water, and the solution is uniformly shaken, and 0.2mol/L sodium hydroxide solution, 8.0g of sodium hydroxide is weighed and dissolved in 1000ml of purified water, and the dissolution medium is obtained by taking 250ml of 0.2mol/L potassium dihydrogen phosphate and 112.0ml of 0.2mol/L sodium hydroxide, diluting the solution with water to 1000ml, and uniformly shaking the solution to obtain 900ml of dissolution medium with the rotation speed of 50 revolutions per minute, operating according to the method, and taking a proper amount of solution and filtering the filtrate when 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes and 60 minutes, and determining the dissolution amount by taking the subsequent filtrate. The results of examples 1 to 5 are shown in Table 2.
TABLE 2
The test results show that the dissolution curve of the roxithromycin capsules of examples 4 and 5 of the invention in phosphate buffer (pH6.8) is obviously superior to that of examples 1 to 3, and is similar to that of the reference preparation.
Meanwhile, by comparing dissolution data, the disintegration condition is known to have influence on the dissolution detection result, and is specifically shown as incomplete dissolution (more than 95%), so that the capsule is determined to have a little content adhesion, which brings trouble to the detection work and result.
Test example 4 stability examination
The sample of the invention example 1 and the reference preparation sample (France cenofil-amphetamine) are placed for 6 months under the conditions of 40 ℃ plus or minus 2 ℃ and 75% plus or minus 5% of relative humidity, and the samples are respectively sampled at the end of 1 st, 2 nd, 3 th and 6 th months, and the change conditions of the characters, the dissolution rates, the related substances and the contents are examined. The test results are shown in Table 3.
TABLE 3
The test results show that the product of the example 5 has the same quality as the reference preparation under the conditions of the temperature of 40 +/-2 ℃ and the relative humidity of 75 +/-5 percent.
Experimental example 5 screening experiment of other adjuvant ingredients in the roxithromycin capsules of the invention:
when the dosage of the povidone K30 is respectively 1%, 3% and 5%, the prescription and data comparison results are shown in the following table: TABLE 3
TABLE 4
By examining the amounts of PVP K301%, 3% and 5% as described above, it was found that the amount of 1% to 5% had no effect on the dissolution results from the product, so the final amount was selected as the low amount of 1%.
Experimental example 6 screening experiments on the operation procedures and the operation conditions in the method for preparing roxithromycin capsules according to the present invention:
the raw material processing mode is considered: firstly, not processing, secondly, sieving after crushing, and the investigation data is as follows:
the raw materials are not treated, so that the dissolution of the product is incomplete, and the raw materials are selected and crushed and then sieved by a 80-mesh sieve.
The above embodiments are provided to aid in understanding the present invention and to enable those skilled in the art to make and use the invention, and are not intended to limit the present invention, and any modifications, equivalents, improvements and the like that fall within the spirit and principle of the present invention should be included in the scope of the present invention.
Claims (5)
1. The roxithromycin capsule is characterized by being prepared from the following components in percentage by weight:
2. the roxithromycin capsule according to claim 1, which is prepared from the following components in percentage by weight:
3. a method of preparing a roxithromycin capsule according to claim 1, comprising the steps of:
a. firstly, pulverizing roxithromycin, sieving the roxithromycin by a 100-mesh sieve, respectively sieving corn starch and low-substituted hydroxypropyl cellulose for later use, and then preparing poloxamer and polyvinylpyrrolidone aqueous solution for later use;
b. weighing and adding roxithromycin, corn starch and low-substituted hydroxypropyl cellulose as raw auxiliary materials, uniformly mixing, and preparing a soft material by using poloxamer and polyvinylpyrrolidone aqueous solution;
c. drying the soft material in a drying box, and sieving the dry particles with a 20-mesh sieve for finishing the particles;
d. weighing silica gel powder as an additional auxiliary material, uniformly mixing with the dry granules, filling capsules, and packaging.
4. The preparation method according to claim 3, wherein the roxithromycin in the step a is crushed and sieved by a 100-mesh sieve, and the corn starch and the low-substituted hydroxypropyl cellulose are respectively sieved by the 100-mesh sieve; the mixing time in the step b is 5-10 minutes; the drying temperature in the step c is 55-65 ℃.
5. The method of claim 4, wherein the mixing time in step b is 10 minutes; the drying temperature in step c is 60 ℃.
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| CN109758433B (en) * | 2019-02-14 | 2020-12-15 | 武汉同济现代医药科技股份有限公司 | Roxithromycin capsule and preparation method thereof |
| CN110151724A (en) * | 2019-05-21 | 2019-08-23 | 海南海力制药有限公司 | A kind of roxithromycin microplate capsule and its manufacturing method |
| CN111658535B (en) * | 2020-06-15 | 2021-11-09 | 花园药业股份有限公司 | System and method for preparing roxithromycin capsules |
| CN112022820A (en) * | 2020-09-04 | 2020-12-04 | 迪沙药业集团有限公司 | Erythromycin ethylsuccinate tablet composition and preparation method thereof |
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| EP1302205A1 (en) * | 2001-10-01 | 2003-04-16 | Ind-Swift Limited | Controlled release formulations of macrolide citrate salts |
| CN103083278A (en) * | 2011-11-04 | 2013-05-08 | 四川科伦药物研究有限公司 | Roxithromycin capsule and preparation method thereof |
| CN106138009A (en) * | 2016-07-29 | 2016-11-23 | 花园药业股份有限公司 | Roxithromycin capsules and preparation technology thereof |
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| EP1302205A1 (en) * | 2001-10-01 | 2003-04-16 | Ind-Swift Limited | Controlled release formulations of macrolide citrate salts |
| CN103083278A (en) * | 2011-11-04 | 2013-05-08 | 四川科伦药物研究有限公司 | Roxithromycin capsule and preparation method thereof |
| CN106138009A (en) * | 2016-07-29 | 2016-11-23 | 花园药业股份有限公司 | Roxithromycin capsules and preparation technology thereof |
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Denomination of invention: A roxithromycin capsule and its preparation process Effective date of registration: 20230829 Granted publication date: 20200811 Pledgee: Industrial Bank Co.,Ltd. Beijing Pinggu Branch Pledgor: BEIJING XINKAIYUAN PHARMACEUTICAL TECHNOLOGY CO.,LTD. Registration number: Y2023110000364 |
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